BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 11120310 · Received January 5, 2021

    Report

    Report Number
    1917413-2020-01285
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 10, 2020
    Report Date
    February 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-01-28. INVESTIGATION SUMMARY: BD RECEIVED 29 CUSTOMER SAMPLES FROM LOT 0289251 AND 1 CUSTOMER SAMPLE FROM LOT 0100190 FROM THE CUSTOMER FACILITY FOR INVESTIGATION ALSO, 1 PHOTO WAS RETURNED TO BE EVALUATED. UPON EVALUATION OF THE CUSTOMER RETURNED SAMPLES AND PHOTO, THE CUSTOMER¿S PRODUCT ISSUE WAS OBSERVED DURING VISUAL INSPECTION AND CONFIRMS THE CUSTOMER¿S CLAIM . ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE INSPECTED WITH THE SAME ISSUE BEING IDENTIFIED. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS FOUND TO BE COMPONENT WEAR WITHIN THE MANUFACTURING PROCESS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED AN INCORRECT FILL LINE POSITION. THIS EVENT OCCURRED ONE TIME EACH WITH SIX DIFFERENT LOT NUMBERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE ARE MULTIPLE FILL LINES ON THE TUBE. MULTIPLE TUBES WITHIN MY ENVIRONMENT APPEARING TO HAVE MULTIPLE "FILL LINES" ON THEM. I AM CONCERNED THAT STAFF COLLECTING COAGULATION SAMPLES WILL NOT FILL THE TUBE TO THE CORRECT FILL LINE. BELOW THE CORRECT MINIMUM FILLED ETCHED LINE ARE TWO ADDITIONAL FAINT LINES THAT CAN BE CONFUSING TO NON-LABORATORY MEDICAL PERSONNEL. THE ADDITIONAL LINES ON THE TUBES ARE VERY MISLEADING AND WILL POTENTIALLY CAUSE UNNECESSARY DELAYS IN PATIENT CARE. THIS ISSUE IS SEEN RANDOMLY IN THE SHELF PACK OF TUBES WITH THE VARIOUS LOT #S LISTED.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0100190, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2020-04-09. MEDICAL DEVICE LOT #: 0133234, MEDICAL DEVICE EXPIRATION DATE: 2021-02-28, DEVICE MANUFACTURE DATE: 2020-05-12. MEDICAL DEVICE LOT #: 0072408, MEDICAL DEVICE EXPIRATION DATE: 2020-12-31, DEVICE MANUFACTURE DATE: 2020-03-12. MEDICAL DEVICE LOT #: 0227238, MEDICAL DEVICE EXPIRATION DATE: 2021-05-31, DEVICE MANUFACTURE DATE: 2020-08-14. MEDICAL DEVICE LOT #: 0258261, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2020-09-14. MEDICAL DEVICE LOT #: 0289251, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2020-10-15. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED AN INCORRECT FILL LINE POSITION. THIS EVENT OCCURRED ONE TIME EACH WITH SIX DIFFERENT LOT NUMBERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE ARE MULTIPLE FILL LINES ON THE TUBE. MULTIPLE TUBES WITHIN MY ENVIRONMENT APPEARING TO HAVE MULTIPLE "FILL LINES" ON THEM. I AM CONCERNED THAT STAFF COLLECTING COAGULATION SAMPLES WILL NOT FILL THE TUBE TO THE CORRECT FILL LINE. BELOW THE CORRECT MINIMUM FILLED ETCHED LINE ARE TWO ADDITIONAL FAINT LINES THAT CAN BE CONFUSING TO NON-LABORATORY MEDICAL PERSONNEL. THE ADDITIONAL LINES ON THE TUBES ARE VERY MISLEADING AND WILL POTENTIALLY CAUSE UNNECESSARY DELAYS IN PATIENT CARE. THIS ISSUE IS SEEN RANDOMLY IN THE SHELF PACK OF TUBES WITH THE VARIOUS LOT #S LISTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14148 BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 SEE H.10 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1